Phone: 1-360-341-6788 1-800-348-4297 FAX: 1-360-341-3676 E-mail: shield@whidbey.com Address: 6111 Cultus Bay Road, Clinton, WA 98236

Since early 1982, ECM Corporation has provided a high quality low cost catheter shield device to the medical profession. The Ray-Marshall Shield is a sterile dressing and self anchoring catheter securement device. The device is approved by the United States Food & Drug Administration, and is used extensively throughout the medical community today.

We provide overnight product shipment to domestic, European and Pacific Rim communities.

Jeremiah Ray, President and Chief Executive Officer of ECM Corporation, is the designer of the Ray-Marshall Shield and is available to answer technical questions directly.

Clinical Experiences

The shield was the subject of extensive clinical trials at Fred Hutchinson Cancer Research Center (FHCRC) Seattle, Washington in February of 1982, and has been used on most patients since May of 1982. Evaluation began with one patient and was gradually extended to other patients as positive results were obtained. Results were gratifying. Excoriated skin has healed within seven days even with neutropenic patients who have undergone combined radiation and chemotherapy, and are suffering from other side effects of the treatment protocols.

To date, no infections at the catheter site have been observed with patients who entered FHCRC without emplaced catheters or who were admitted with infection free catheter sites. This is in marked contrast to the infection rate reported for 120 patients whose catheters were maintained by other procedures. (See J.H. Sanders, et al, Experience with Double Lumen Right Arterial Catheters, Journal of Parenteral and Enteral Nutrition, 6:95-99, 1982).

In addition, it appears that the evaluation of the catheter pivot point by the shield dome plus the tape collar has markedly reduced (or in some cases eliminated) tissue irritation due to catheter motion. This is apparent by reduction or disappearance of the reddened tissue around the catheter. To date, no incidence of catheter damage or any patient problem has been reported.

Shields have been used on many thousands of patients at FHCRC. It is also used in other Seattle area hospitals including Swedish Hospital, University of Washington Hospital, Seattle Veterans Administration Hospitals (and VA hospitals nationwide), and Providence Memorial Hospital and are now an accepted part of the standard nursing protocol. In some cases, tape/gauze dressings are used for seven days after catheter placement. Shields are then used for the remaining 100 or more days that the catheter remains in place. The RMS is additionally used at such nationally acclaimed hospitals as Mt. Sinai, The Mayo Clinic and Hospital, and Georgetown University.

In May of 1985, The Ray Marshall Shield (RMS) was introduced by the Nursing staff in the Mobile Trauma Unit at Memorial Sloan Kettering Cancer Center (MSKCC), New York City, as an alternative dressing for long term catheters (i.e. Broviac catheters). An evaluation tool was developed by the MTU Nurse Clinician Department of Nursing Research.

During the 5 month period of May to October 1, 12 patients used the RMS as an alternative to the standard dressing. The following is a summary of the data collected. Two patients refused the RMS reporting that they would feel more comfortable using the standard gauze dressing.

Types of Indwelling Catheters

Ten patients had double lumen catheters inserted for at least a two week period. One patient had a second catheter, a single lumen. Eleven Ray Marshall Shields were used and evaluated. These evaluations were conducted during the regularly scheduled dressing changes twice daily. The length of evaluation period averaged 9 data collections over a 4 week period.

The following variables were included in the data collection form:

1. Skin Integrity:

Redness: Two of the ten patients had minimal redness around the catheter site. One patient on an initial assessment was rated as having severe redness, however this subsided within two days.

Swelling: Of ninety Measures recorded by nurses, there was one record of swelling, which did not reappear over the following month of use.

Patient discomfort / pain: Three patients reported a pulling sensation during a dressing change.

Drainage: There were no reports of drainage around the catheter site.

2. Bacterial Cultures: 4 of 13 lines had 0 (zero) c/s at site (one gram - and three staph epidermis).

3. Neutrophil Counts: All patients neutrophil counts went to 0 (zero) during study.

4. Catheter Integrity: No patients were observed to have catheter leakage, breakage or indentation during the evaluation period.

5. Length of Catheter: Length was measured at each dressing to insure catheter placement. Changes in length of 1 to 2 cm were recorded by different evaluators. The majority of observations however were zero (meaning no change in placement).

6. Patient Opinion:

Comfort: Two of ten patients reported discomfort with the RMS and decided to return to the standard dressing.

Case of use: All patients reported positively in reference to the case in using the RMS.

Continued use with the RMS: Six patients were discharged and instructed in the care and use of the RMS.

Evaluators Opinions

Nurses overall opinions of the RMS were mostly positive. Comments made by nurses included:

It is easy to monitor any redness which can develop due to the clear plastic shield.

It is especially beneficial for patients with skin breakdown because of the little or no tape required for placement.

It is easy to teach patients self care techniques needing only two Betadine swabs and an RMS for dressing changes.

It is less costly to the patient.

The RMS is not for all patients and should be offered as a choice to the standard bulky dressings.

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